Who is the idiot that put the active participants in an ongoing criminal enterprise in charge of protecting the victims?

The author's relevant Conflicts of Interest:
I am biased.  My son is a Risperdal victim.  J&J started illegally marketing the drug as soon as it was FDA approved. All due respect to the Justice Department, the investigation going back to 2004, is not going back far enough. J&J had been illegally marketing Risperdal for close to a decade by 2004. The DOJ fines and penalties are very small % of the money that J&J defrauded from the American people through Medicaid and Medicare, and have not caused J&J to alter the unethical manner in which business is conducted. More importantly, these fines and penalties do not help J&J's PRIMARY VICTIMS who are grievously harmed. There is no way to compensate those who mourn the loss of a family member, the parents and children of J&J's victims who were killed by iatrogenic homicide. How can it ever rectify the harm done to Risperdal  victims who were further victimized because the adverse effects of Risperdal were attributed to the patient's  "psychiatric disease," or attributed to yet another psychiatric disease, which required adding a comorbid diagnosis?  It does nothing for the parents who are taking care of an adult child that is disabled like my son is? My son requires a great deal of assistance, and probably will for the rest of his life. Don't misunderstand me, it is an honor and a priveledge to take care of my son; but, it is also a tragic that it is even necessary.  

a screen shot from Sheller FDA Petition Comments

I am getting real tired of the "news reports" in the mainstream media which are about risk for diabetes and obesity from the neuroleptic drugs, called "antipsychotics." Children are being prescribed neuroleptic drugs for virtually any and every diagnosis---this is clearly Human Experimentation, occurring in Standard Clinical Practice; referring to it as "off label prescribing" implies that that there is some statistically relevant evidence which supports using these teratogenic drugs with fatal risks in the manner they are being used. The evidence does not even support using the drugs for the diagnosis of schizophrenia as a "first-line treatment," the condition for which the drugs were originally developed and prescribed for.

The very real risks of obesity and diabetes however are not, at least in my mind, what is most alarming about the fact that so many children are being prescribed neuroleptic drugs; nor is the fact that the American people are being defrauded through Medicaid (still!) in order to pay for these "off label" prescriptions over 90% of the time.  Nor is it that journalists are failing to ethically report on any of the issues involved with prescription drugs, with rare exception. The articles are often lost amongst the prescription drug advertising and the press releases journalists publish without verifying the veracity of any of the "facts" which the press releases contain...I accept that this is what is passes for "reporting the news."  There is very little reporting in the mainstream news about the rampant fraud in academic research, there is even less about the questionable (to say the very least) FDA approval process; this keeps people misinformed, dangerous drugs stay on the market, and keeps people are unaware of the risks involved when seeking psychiatric treatment. Once drugs are  FDA approved, the manufacturers rarely do the required after-market testing, and are never held accoutable for this failure.  There is little effort to no effort invested in regulating the marketing of FDA approved drugs so there are no meaningful consequences for making false claims in direct-to-consumer and direct-to-professional marketing of FDA approved drugs.  Apparently, the fact that people are being harmed at an alarming rate, is not "news," it is rarely reported. All of this is due to the unethical conduct of public servants with glaring conflicts of interest, which is also rarely if ever, reported by mainstream journalists.

Add to this obfuscation of the facts regarding psychiatric diagnoses and the toxic teratogens used to "treat" them, is the fact that adverse effects (including death) do not have to be reported to the FDA by medical professionals--If the FDA's primary purpose is to protect people from the risks of prescription drugs, adverse events and adverse effects is data that should be required reporting, it is needed order to effectively assess a drug's safety profile.  The FDA's primary purpose is not to protect the American people from the risks for harm, if it were, prescribers would be required to report adverse effects and adverse events. Protecting patients from harm is only a stated purpose; it is a marketing tool, a cover story. I don't believe protecting the American people was ever the FDA's primary purpose; it certainly is not a purpose that is effectively or ethically served currently.

The primary purpose served by the modern FDA is to protect the interests of the pharmaceutical industry. People who are given a psychiatric diagnosis are automatically at risk for experiencing grave harm because diagnostic criteria and treatment standards are developed by consensus; and consensus is regularly substituted for empirical data.  There are two reasons for this, the first reason is there is insufficient evidence, and the second reason is the evidence does not support the marketing agenda in which it is claimed drugs sagfely and effectively treat a diagnosis.  Psychiatry in this way ignores ethical scientific research standards; and it is abdicates it's responsibility for exercising sound, ethical medical judgement. It is a systematic way to standardize Human Experimentation on people who are given a psychiatric diagnosis in standard practice. The unethically developed "Standards of Care" become an affirmative defense for unethical medical practice, they are in this used by professionasl to abdicate any and all liability for harm to patients. Calling it a Standard of Care when it ignores ethical, scientific research and ethical medical practice standards is such utter BS---no one can possibly believe deception, fraud, and unethical behavior are necessary to provide mental health care. It is a way to rationalize, justify and codify unethical behavior; it serves to absolve doctors of liability for the grievous harm inflicted on patients using dangerous drug saccording to unethical standards.

In standard clinical mental health practice, there is no empirical data that is used to objectively diagnose a person. More often than not, there is no evidence that would support the recommended treatment.  The treatment is usually teratogenic drugs with fatal risks, and/or electroshock. The reality is there is very little science and a whole lot of consensus. Consensus is evidence of agreement; it is not evidence of diagnostic validity; it is not an ethical basis for a medical treatment, much less a basis to force a person, since it does have the serious risks of causing disability and death! Patients are at a serious disadvantage, as soon as a psychiatric diagnosis is attached. Rarely is the harm done to them reported. In my experience, as the mother of a child who was the victim of a violent assault, once a psychiatric diagnosis was attached, the harm done to my son, including felony crimes committed by "professionals," can be reported; but are never investigated.

Adverse reactions from drugs, (if even recognized as an adverse reaction) are attributed to the psychiatric "disease" the patient is diagnosed with. The way the mental health psychiatric system is set up, the direct adverse effect of diagnosis and treatment upon the patient is not relevant; negative effects are rarely acknowledged, if at all. These effects are purposely not being collected; consequently the harm cannot be quantified by those with an ethical duty to do so. Indeed, the people who have an ethical and a legal duty to, "First, do no harm..." are covering up the evidence that they are doing a great deal of harm to a great number of victims whom they call patients. The majority of these victims are poor children and foster children on Medicaid, the elderly on Medicare, and traumatized Veterans on Tri-Care. They all have one thing in common: they were seen as a means to an end. Their psychiatric stigmatization was the means and meeting the marketing goals of the pharmaceutical industry was the financially lucrative ends. these particular populations were targeted for diagnosis and treatment because they had medical benefits which would pay the costs of their "care." They were used because the American people had seen fit to ensure these vulnerable people had their medical needs provided for. Pharma's illegal marketing campaigns targeted those among us who are the most vulnerable, and least capable of effectively defending themselves to meet their marketing goals...Isn't that special?

Back to my original point, the things that are NOT being discussed are the serious adverse effects on sexual functioning that Risperdal and other psychotropic drugs have on human beings.  We are allowing children who are not sexually mature, to be given drugs which adversely effect normal sexual development and functioning; in effect, ensuring that many will never be capable of having a normal sexual relationship. If that is not a risk which should be of concern to their parents and the professionals who are alarmed about the diabetes and obesity risk, than I am Mary freaking Poppins! The rate children are being disabled and killed is not even MENTIONED by any of the "stake-holders" involved in the frantic efforts undertaken (supposedly on the behalf of foster children) when the THIRD Senate investigation was launched into the off label prescribing of teratogenic drugs to vulnerable children. The very people who we entrust to take care of our Nation's foster children do not appear to be concerned at all about how many of the children have been disabled and killed due to the direct negative effects of off label prescriptions taken as directed.  These are relevant facts which should be part of the discussion; however, they are in fact being ignored by the paid public servants in Child Welfare, Academic Researchers paid to do drug and psychiatric treatment research, grassroots advocates claiming to be the Nation's voice on mental illness, The American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry.

Well I am WIDE awake and I want to know why are the worst risks faced by these children for brain damage, sexual development, and sexual dysfunction, sudden death, and chronic neurological impairment are being ignored by those who are "concerned." The study below is over; as usual, results are not available...

But more than this, I want to know who is the idiot who thought putting active participants in an ongoing criminal enterprise, in charge of protecting their victims was a good idea? 

Clinical Trials.gov
An Observational Study to Evaluate the Safety and the Effects of Risperidone Compared With Other Atypical Antipsychotic Drugs on the Growth and Sexual Maturation in Children

This study has been completed.

Sponsor:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Information provided by:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

ClinicalTrials.gov Identifier:

NCT01050582

First received: January 14, 2010

Last updated: May 25, 2012

Last verified: May 2012

History of Changes

  Purpose

The purpose of this observational study is to evaluate risk of prolactin-related adverse events (side effects) and the effects of risperidone compared with other atypical antipsychotic drugs on the physical maturity, growth and development of children exposed to these drugs

Condition	Intervention	Phase
Schizophrenia Bipolar Disorder Autistic Disorder Attention Deficit and Disruptive Behavior Disorders	Drug: Risperidone Drug: Other atypical antipsychotic drugs	Phase 4

Study Type:	Interventional
Official Title:	Evaluation of Growth, Sexual Maturation, and Prolactin-Related Adverse Events in the Pediatric Population Exposed to Atypical Antipsychotic Drugs

Resource links provided by NLM:

MedlinePlus related topics: Autism Bipolar Disorder Schizophrenia

Drug Information available for: Prolactin Risperidone

U.S. FDA Resources 

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

• To compare Z-scores for height, age at current Tanner stage, and prolactin-related adverse events between patients exposed to risperidone and patients exposed to other atypical antipsychotic drugs. [ Time Frame: During the study visit and retrospectively during the time of exposure for up to 2 years prior to the study visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

• Assess the prolactin value and risk of hyperprolactinemia associated with risperidone as compared with other atypical antipsychotic medications in a pediatric population. [ Time Frame: One time during the study visit ] [ Designated as safety issue: Yes ]
• Identification of subgroups of patients at high risk for changes in height or maturation. [ Time Frame: During the study visit and retrospectively during the time of exposure for up to 2 years prior to the study visit ] [ Designated as safety issue: No ]

Enrollment:	244
Study Start Date:	October 2009
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 001 Risperidone As per local prescribing practices	Drug: Risperidone As per local prescribing practices
No Intervention: 002 Other atypical antipsychotic drugs As per local prescribing practices	Drug: Other atypical antipsychotic drugs As per local prescribing practices

  Show Detailed Description

  Eligibility

Ages Eligible for Study:	8 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• One or both parents (according to local regulations) or a guardian must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study (If appropriate according to local regulations, the patient must also assent)
• Treated for schizophrenia, bipolar mania, autistic disorder, or conduct and other disruptive behavior disorders
• Had at least 6 months of exposure for an atypical antipsychotic drug within 24 months before the study visit (patients may or may not be taking the atypical antipsychotics at the time of actual enrollment, eligible patients can have exposure to multiple atypical antipsychotics, however, they cannot concomitantly be exposed to more than 1 atypical antipsychotic for a period of greater than 30 days)
• Had medical records or automated data available for at least 1 year prior to the start of exposure
• Height and weight were recorded at least once within 1 year before the start of exposure, and if available at any time points after the start of exposure in the medical records or electronic databases (not mandatory)

Exclusion Criteria:

• Have at least 1 medical record, at any time before the start of exposure, consistent with malignancy (other than non-melanoma skin cancer), pregnancy, or a developmental delay or abnormality associated with growth or sexual maturation delays not related to the specified indications
• Had exposure to prolactin elevating medications other than atypical antipsychotics and selective serotonin reuptake inhibitors (SSRIs)
• Had exposure to Paliperidone
• Cannot comply with study procedures

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050582

  Hide Study Locations

Locations

United States, California

San Francisco, California, United States

United States, Colorado

Aurora, Colorado, United States

United States, Florida

Altamonte Springs, Florida, United States

Gainesville, Florida, United States

United States, Georgia

Smyrna, Georgia, United States

United States, Illinois

Naperville, Illinois, United States

United States, Indiana

Indianapolis, Indiana, United States

Valparaiso, Indiana, United States

United States, Massachusetts

Boston, Massachusetts, United States

Cambridge, Massachusetts, United States

United States, New York

Glen Oaks, New York, United States

United States, Ohio

Cleveland, Ohio, United States

Columbus, Ohio, United States

Belgium

Antwerpen, Belgium

Germany

Freiburg, Germany

Jena, Germany

Mannheim, Germany

München, Germany

Tübingen, Germany

Ulm, Germany

Würzburg, Germany

Greece

Athens, Greece

Netherlands

Nijmegen, Netherlands

Poland

Gdansk, Poland

Kielce, Poland

Lódź, Poland

Sosnowiec, Poland

Warszawa, Poland

Warszawa N/A, Poland

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  More Information

No publications provided

Responsible Party:	Clinical Leader Psychiatry, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT01050582     History of Changes
Other Study ID Numbers:	CR016687
Study First Received:	January 14, 2010
Last Updated:	May 25, 2012
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Schizophrenia Bipolar Disorder Autistic Disorder Attention Deficit and Disruptive Behavior Disorders Risperidone

RISPERDAL Antipsychotic Agents Prolactin Pediatrics

Additional relevant MeSH terms:

Schizophrenia Child Development Disorders, Pervasive Schizophrenia and Disorders with Psychotic Features Autistic Disorder Mental Disorders Bipolar Disorder Attention Deficit and Disruptive Behavior Disorders Attention Deficit Disorder with Hyperactivity Mental Disorders Diagnosed in Childhood Affective Disorders, Psychotic Mood Disorders Antipsychotic Agents Risperidone

Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Dopamine Antagonists Dopamine Agents

ClinicalTrials.gov processed this record on October 03, 2012